- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01921049
Systemic Inflammatory Response Syndrome (SIRS) in Patients Undergoing Major Procedures in Oral and Maxillofacial Surgery
December 7, 2014 updated by: Dr. Wolfgang A. Wetsch, University of Cologne
Patients undergoing major procedures in oral and maxillofacial surgery more often develop a systemic inflammatory response syndrome (SIRS) in the first days of postoperative critical care therapy than patients with a comparable major surgery in other regions.
The reasons for this finding are unknown and have not been studied in depth so far.
We hypothesize that surgical trauma in this region might activate pro-inflammatory pathways.
By examining the proteome of patients at different stages (prior to the surgery, at ICU admission, on the second postoperative day and when SIRS has ended clinically), we aim to identify the involved pro-inflammatory pathways and identify possible target proteins that might be clues to modification of postoperative SIRS in the future.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
27
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Cologne, Germany
- Department of Anaesthesiology and Critical Care Medicine, University Hospital of Cologne
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
all patients undergoing major procedures in oral and maxillofacial surgery during the study period
Description
Inclusion Criteria:
- age 18-99yrs
- scheduled for elective surgery with risk for development of SIRS
- written and informed consent
Exclusion Criteria:
- age <18yrs
- pregnancy
- emergency surgery
- failure to obtain patient consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change of concentration of pro-inflammatory cytokines [µg/l]
Time Frame: up to 10 days post surgery
|
Change of concentration of pro-inflammatory cytokines from pre-operative sample over icu-admission, 2nd postoperative day and clinical end of SIRS.
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up to 10 days post surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wolfgang A. Wetsch, M.D., Department of Anaesthesiology and Critical Care Medicine, University Hospital of Cologne
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
August 6, 2013
First Submitted That Met QC Criteria
August 8, 2013
First Posted (Estimate)
August 13, 2013
Study Record Updates
Last Update Posted (Estimate)
December 9, 2014
Last Update Submitted That Met QC Criteria
December 7, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-229
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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